DESCRIPTION OF INSTITUTE-INITIATED PROGRAMS IN PREVENTION RESEARCH

The NHLBI Clinical Applications and Prevention Program supports research into primordial, primary, and secondary prevention of heart and vascular, pulmonary, and blood diseases through activities such as clinical trials, studies of health promotion and disease prevention interventions, community intervention trials, health education research, nutrition research, and behavioral medicine studies. The clinical trials program supports large-scale, multicenter clinical trials involving hypertension, cardiac arrhythmias, coronary artery disease, heart failure, hyperlipidemia, and thrombosis. The behavioral medicine program encourages basic and clinical collaborations between biomedical and behavior scientists. The prevention program supports research to test effectiveness and demonstrate capability of preventive interventions that are designed to prevent or reduce cardiovascular risk factors. The prevention research portfolio includes efficacy, effectiveness, and translational studies addressing primordial, primary, or secondary prevention of cardiovascular diseases. Topics include health behaviors (diet, physical activity, and smoking), CVD risk factors (hypercholesterolemia, hypertension, obesity, and diabetes), and early detection and treatment of acute cardiac events. Ongoing programs include studies of prevention and treatment of hypertension; hyperlipidemia, obesity, and other risk factors in children and adolescents; the response of patients and medical care systems to symptoms of cardiovascular disease; and community-wide prevention programs.

The program administers several large multi-faceted trials that address a variety of research objectives, many related to the recommendations of the Task Force on Research in Epidemiology and Prevention of Cardiovascular Disease. These studies are described below in the order in which they were initiated and are referenced in the summary of research activities under each applicable priority area recommendation.

Cooperative Agreements and Contracts

Dietary Intervention Study in Children (DISC) (1986-1998)

This multi-center randomized controlled trial of children with elevated LDL-cholesterol levels tested the long-term efficacy and safety of a dietary intervention to reduce elevated blood cholesterol levels. Children were ages 8-10 at baseline. The main results from three years of intervention were published in 1995. The study was continued after the first three years of intervention in order to assess the long-term effects of the dietary intervention on LDL-cholesterol as well as on near-adult stature. The continuation was investigator-initiated. The main results paper of the continuation is currently being developed.

Children and Adolescent Trial of Cardiovascular Health (CATCH) (1987-2000)

CATCH was an Institute-initiated 96-school multi-center randomized school trial of a school-wide intervention to improve CVD-related behaviors (dietary, physical activity, and smoking) of elementary schoolchildren. The main results of the intervention component were published in 1996. A follow-up observational study will be completed in 1999, and an observational study of the institutionalization of the CATCH curriculum was begun in 1998. The follow-up and institutionalization portions of CATCH were investigator-initiated. CATCH is relevant to population-based approaches to primordial and primary prevention.

Prevention and Treatment of Hypertension Study (PATHS) (1988-1994)

This multi-center randomized trial tested the effects on BP of a behavioral intervention to reduce alcohol intake in men with moderately heavy alcohol intake and above-optimal diastolic BP.

Trials of Hypertension Prevention II (TOHP II) (1990-1998)

This is the second in a series of two multi-center trials of adults with high normal BP levels that have tested the efficacy of various interventions on BP. TOHP II tested, in a multicenter randomized trial, the separate and combined effects on BP levels of weight reduction and dietary sodium reduction (the two successful interventions from TOHP I). The main results were published in 1997. TOHP II was Institute-initiated. TOHP is relevant to hypertension prevention and treatment.

Evaluation of Adherence Interventions in Clinical Trials (1992-1997)

This Cooperative Agreement was co-sponsored by the National Institute for Nursing Research to develop cost-effective strategies for enhancing adherence to the intervention regimens in clinical trials, thus improving the efficiency of clinical trials. Funds were provided to compare the effectiveness of different intervention strategies in several ongoing clinical trials.

Pathways (1993-2001)

This Institute-initiated multi-center randomized school trial is testing a school-based intervention to reduce the development of obesity in Native American schoolchildren by improving diet and increasing physical activity levels through a school-wide intervention program. Pathways began with a feasibility phase; the main study is currently being implemented. Pathways is relevant to population-wide prevention strategies as well as primordial prevention of obesity in a high-risk, underserved population of lower SES.

Dietary Approaches to Stop Hypertension (DASH) (1993-1997) and DASH-Sodium (1997-2001)

A multi-center randomized feeding trial, DASH examined the efficacy of two dietary patterns, compared to control, on BP level using a randomized feeding-study design in adults with high normal BP to stage 1 hypertension. DASH began in 1993 and the main results were published in 1997. DASH-Sodium, which began in 1997 and is currently in the field, is a multi-center trial testing the most efficacious dietary pattern from DASH at three levels of dietary sodium. DASH was Institute-initiated; DASH-Sodium was investigator-initiated. Results from DASH are relevant to both hypertension prevention and treatment. DASH and DASH-Sodium recruited one-half to two-thirds minority participants because of the importance of hypertension in Blacks.

Activity Counseling Trial (ACT) (1994-1999)

This Institute-initiated multi-center randomized clinical trial tested the effects of two patient education and counseling programs compared to standard care on fitness and physical activity levels of sedentary primary care patients. The programs tested were designed to be feasible for delivery by health care practitioners. Since ACT focuses on physical inactivity as a CVD risk factor, it is relevant to primary and primordial prevention.

Antihypertensive and Lipid lowering Treatment to Prevent Heart Attack (ALLHAT) (1994-2002)

ALLHAT is a major Institute-initiated multi-center study that is testing the effectiveness of various classes of antihypertensive medications in reducing CHD morbidity and mortality in 42,000+ older hypertensive patients, as well as the effectiveness of blood cholesterol-lowering in 10,000+ patients with moderately high LDL-cholesterol. ALLHAT is currently in the intervention and follow-up phase.

Rapid Early Action for Coronary Treatment (REACT) (1994-2000)

This randomized multi-center community trial addressed secondary prevention (early detection and treatment) by developing and evaluating the impact of a community educational program on patient delay time from onset of acute MI symptoms to arrival at a hospital Emergency Department. The main results paper is under preparation. The study is relevant to secondary prevention (early detection and treatment) as well as population-wide approaches to intervention. In addition, the study communities had substantial proportions of lower SES and minority residents.

Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) (1995-2003)

ENRICHD is a multi-center clinical trial testing effects of interventions for depression and social isolation on morbidity and mortality of CHD patients. ENRICHD includes data on socioeconomic status, and will include a significant proportion of participants from low as well as high SES strata as well as about 30% minorities. These data will provide important insights on relationships between SES and morbidity and mortality following acute myocardial infarction.

Premier: Lifestyle Interventions for Blood Pressure Control (1998-2003)

This multi-center randomized trial is examining the effectiveness of the combination of currently recommended lifestyle interventions, including dietary sodium reduction, weight reduction, and physical activity, with and without the DASH diet, on BP level. Participant recruitment is underway. Premier was investigator initiated. Because Premier includes participants with high normal BP as well as stage I hypertension, it is relevant to primordial and primary prevention. Premier will enroll half minority participants.

Girls health Enrichment Multi-Site Studies (GEMS) (1999-2007)

This multi-center research program is developing and testing promising interventions to reduce weight gain in African-American pre-pubertal girls in order to prevent future obesity. A 2.5-year intervention development and pilot phase will be followed by randomized trials in four sites, each testing a unique intervention. The initiative concept was developed in conjunction with the SEP on children's intervention studies held in 1997.

Action to Control Cardiovascular Complications in Diabetes (ACCORD) (Previously Prevention of Cardiovascular Disease in Diabetes Mellitus (1999-2008)

This is a multi-center randomized clinical trial comparing strategies for treating hyperglycemia, elevated blood pressure, and lipids/lipoproteins for reducing the risk of major cardiovascular events in patients with Type 2 diabetes. The study will enroll approximately 10,000 participants. This initiative was developed in conjunction with the SEP on CVD in DM held in 1997.

Study of Health Outcomes of Weight Loss (SHOW) (1999-2008)

This is a multi-center randomized clinical trial sponsored by NIDDK with collaboration by NHLBI. The purpose of the study is to test the effects on CVD development of intentional weight loss in overweight persons with type 2 diabetes. The study will enroll approximately 6,000 participants.

Trial of Activity in Adolescent Girls (TAAG)

This is a multicenter school-based trial to test a school-community linked intervention to prevent the decline in physical activity in adolescent girls to be funded in fiscal year 2000. The concept was developed in conjunction with the NHLBI/NINR SEP on children's intervention studies held in 1997.

Program Announcements and Grant RFAs

Studies of Children's Activity and Nutrition (SCAN) (1985-2001)

The purpose of this Institute-initiated program was to support longitudinal studies to track the acquisition of dietary and physical activity behaviors in children beginning at 3-4 years of age. Three studies of the original eight that were funded have been continued to follow their cohorts in order to examine long-term trends and behavioral determinants. The continuations were investigator-initiated, and three currently continue to be funded.

Smoking Cessation Strategies for Minorities (1989-1997)

This Request for Applications was issued to stimulate the development of smoking cessation and relapse prevention programs specifically designed for minority populations, in which cessation success rates were lower than in the general population. The goal of the program was to develop culturally sensitive smoking cessation programs and smoking education materials based on the needs of different groups. Research grants funded under the program included programs targeting Native Americans and minority groups of Hispanic, Asian, and African origins.

Improving Hypertensive Care for Inner City Minorities (1993-1997)

Five studies were funded under this Institute-initiated RFA program to develop and evaluate for feasibility, acceptability, and effectiveness methods to maintain therapy and control of hypertension in inner-city minority populations.

CVD Nutrition Education for Low-Literacy Skills (1994-1996)

This program funded seven studies to develop and evaluate nutrition education programs designed to improve dietary practices and reduce nutrition-related CVD risk factors in adults with low-literacy skills.

Physical Activity and Cardiopulmonary Health (1994)

This Program Announcement was released by NHLBI, NIDDK, and NINR to stimulate studies in the area of physical activity related to cardiopulmonary health, and focused on dose-effect relationships of physical activity and health outcomes. An addendum was released in 1996 to encourage additional applications. The PA is relevant to primordial and primary prevention. It encourages studies in diverse populations.

Diet and Cardiovascular Disease Risk in Children and Adolescents (1998)

The purpose of this Program Announcement, jointly released by NHLBI and NINR, is to seek research applications for investigator-initiated studies relevant to the development and/or testing of dietary interventions to improve the cardiovascular disease (CVD) risk profiles in children and adolescents. The initiative concept was developed based on recommendations by the NHLBI/NINR SEP on intervention studies in children to prevent CVD held in 1997. The PA encourages studies in diverse populations.

Innovative Approaches to Disease Prevention through Behavior Change (1998)

This RFA was co-sponsored by seventeen NIH Offices and Institutes to support research comparing alternative theories of mechanisms through which health-related behavior change occurs, and to assess the utility of specific theoretical models for promoting behavior change in co-occurring behavioral risk factors. In addition, the program emphasizes research on applicability of interventions to vulnerable populations and diverse ethnic and minority groups, and on long-term maintenance of behavior change.

Methodology and Measurement in the Behavioral and Social Sciences (1998)

This Program Announcement was co-sponsored by 11 Institutes and Offices of NIH, including NHLBI. The purpose is to invite qualified researchers to submit research grant applications on methodology and measurement to improve the quality and scientific power of data collected in the behavioral and social sciences. The topics include several of interest to cardiovascular disease prevention, such as measurement of self-reported behaviors such as diet and physical activity, as well as measurement of stress, quality of life, SES, and race/ethnicity. Methodology and measurement issues related to diverse populations are emphasized.

Socioeconomic Status and Health Across the Life Course (1998)

The purpose of this Program Announcement, sponsored by five NIH Institutes, including NHLBI, was to encourage grant applications examining the cumulative and contemporaneous relationships between socioeconomic status (SES) and physical and mental health and functioning over the life course and across generations.

Innovative Approaches to Prevention of Obesity (1999)

This RFA was co-sponsored by 6 Institutes and Offices of NIH, including NHLBI. The purpose is to fund innovative pilot studies testing approaches for the prevention of obesity in high-risk individuals, families, or populations.

Training Programs

Nutrition Academic Award (NAA) (1998-2003)

This training program was initiated to fund 15 medical schools to develop, implement, and evaluate curricula and other training opportunities for medical students, residents, and ancillary medical personnel to learn nutrition principles and clinical practice skills, with an emphasis on preventing cardiovascular disease. Ten awards have been made, with additional awards to be made in 2000. This training program is relevant to primordial, primary, and secondary prevention, and to both children and adult patients.

Clinical Research Curriculum Award (K30) (1998)

An RFA was released to award institutions to address, in part, the NIH's initiative to improve the quality of training in clinical research. The purpose of the award is to support the development of new didactic programs in clinical research at institutions that do not currently offer such programs, or to support or expand programs in institutions with existing didactic programs. Clinical research includes patient-oriented research, epidemiologic and behavioral studies, and outcomes of health services research.

Mentored Patient-Oriented Research Career Development Award (K23) (1998)

The purpose of this award is to support the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented research. This mechanism provides support for a period of supervised study and research for clinically trained professionals who have the potential to develop into productive, clinical investigators focusing on patient-oriented research. Patient-oriented research is defined as research conducted with human subjects, including: 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials, and; 4) the development of new technologies.

Workshops and Special Emphasis Panels

Conference on Socioeconomic Status and Cardiovascular Health and Disease (1995)

The Institute conducted a conference on the relationship between socioeconomic status and cardiovascular health in 1995. This conference led to a number of research recommendations, and stimulated research on the causes of inequalities in health in different socioeconomic strata.

Community Trials for Cardiopulmonary Health: Directors for Public Health Practice, Policy, and Research (1996)

NHLBI previously funded several community-intervention studies to reduce CVD risk factors: the Stanford Five City Project, the Pawtucket Heart Health Program, and the Minnesota Heart Health Program. In 1996 NHLBI held a workshop to examine the results of these and other studies to assess the implications for practice and for future research recommendations for population-wide strategies in communities, schools, worksites, health-care institutions, and community organizations, such as churches. The workshop produced a journal supplement to publish the assessments and research recommendations.

Special Emphasis Panel on Intervention Studies in Children and Adolescents to Prevent CVD (1997)

This SEP was held to obtain recommendations from the research community on directions for children's research. Potential initiative concepts were reviewed and research recommendations were obtained from the attendees. The major focus was primordial prevention, though primary prevention was also addressed.

Special Emphasis Panel on Macrovascular Disease in Diabetes Mellitus (1997)

This SEP was held to obtain research recommendations for examining approaches to prevent CVD in adult-onset diabetes mellitus.

Workshop on Maintenance of Behavior Change in Cardiovascular Risk Reduction (1998)

A workshop on maintenance of behavior change was held in 1998 to examine the science base for maintenance of healthful lifestyle behaviors and to provide recommendations for future research. Behaviors examined included diet, physical activity, smoking, and obesity. Manuscripts for publication in the scientific literature are currently being finalized. The workshop is relevant to primordial, primary, and secondary prevention.

Workshop on Assessing Risk for Coronary Heart Disease (1999)

A workshop was held in 1999 to explore the applicability of CHD risk assessment from the Framingham Heart Study data and to utilize information from other datasets to expand knowledge regarding risk assessment in diverse population.

Workshop on Sodium and Blood Pressure (1999)

A workshop held in 1999 examined the current state-of-the-science regarding the effects of sodium on blood pressure.

Working Group on Adherence to Medical and Lifestyle Interventions (1999)

A working group meeting was held in 1999 to examine what is known about enhancing adherence in clinical care and community settings, to explore innovative, multi-level approaches to resolving the challenges in this area, and to advise NHLBI on developing and prioritizing initiatives for both research and applications.

National Conference on Cardiovascular Disease Prevention (1999)

The goal of this trans-agency national conference, held in 1999, was to assess the magnitude and causes of trends in coronary heart disease, stroke, and other cardiovascular diseases. The conference provided a summary of the current status of CVD in the U.S. to allow development of a more comprehensive and effective research and prevention agenda for the 21^st century.